Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.

Date publication

mars 2016

Journal

The Lancet. Haematology

Auteurs

Membres identifiés du Cancéropôle Est :
Pr DELMER Alain

Tous les auteurs :
Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/26947201

Résumé

Part one of the two-part SAWYER study predicted that subcutaneous rituximab 1600 mg would achieve trough serum concentrations that were non-inferior to those achieved with intravenous rituximab 500 mg/m(2) in patients with chronic lymphocytic leukaemia. In part two of the study, we aimed to confirm the pharmacokinetic non-inferiority of subcutaneous rituximab, and investigate its safety and efficacy.

Mots clés

Administration, Cutaneous, Administration, Intravenous, Adult, Aged, Antineoplastic Agents, administration & dosage, Antineoplastic Agents, Alkylating, administration & dosage, Antineoplastic Combined Chemotherapy Protocols, Cyclophosphamide, administration & dosage, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, drug therapy, Male, Middle Aged, Rituximab, administration & dosage, Treatment Outcome, Vidarabine, administration & dosage

Référence

Lancet Haematol. 2016 Mar;3(3):e128-38